Menstrual device and applicator system

ABSTRACT

A menstrual device having a storage volume. The menstrual device has a frame and a fluid barrier seal layer attached to the exterior surface of the frame. The menstrual device has an expanded configuration that includes an at rest configuration and a deployed configuration. The menstrual device has a compact configuration where the menstrual device is confined to a size, shape and/or geometry smaller than an expanded configuration such that it can be more easily inserted into the body. The menstrual device in a compact configuration is contained within an applicator, where the applicator assists in ejecting the menstrual device into the body.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Patent ApplicationSer. No. 62/341,131, filed on May 25, 2016, and also to U.S. ProvisionalPatent Application Ser. No. 62/341,134, filed on May 25, 2016, both ofwhich are incorporated in their entirety herein.

BACKGROUND OF THE DISCLOSURE 1. Field of the Disclosure

Aspects of the present disclosure generally relate to feminine hygieneproducts. More particularly, the present disclosure relates to femininehygiene products relating to menstruation.

2. Description of Related Art

There are various types of devices that are currently used in an effortto prevent a flow of fluid (e.g. menses) from soiling a user's clothing.Two of the more common devices used for such a purpose are a tampon anda menstrual cup. A tampon operates on a principle of absorbing bodilyfluids, whereas a menstrual cup operates on a principle of collectingbodily fluids.

Tampons have gained wide acceptance in the overall feminine care marketbased at least in part on the relative ease of disposal following use,the tendency of a tampon to conform to the user's individual anatomy,and the potential ease of insertion via an “applicator” (sometimesreferred to as an “inserter” in the art). However, in some instancestampons may have a tendency to dry a user's vaginal wall, and may have alimited effective utilization time period (e.g., depending on the volumeof menstrual flow), Prior art menstrual cups, on the other hand, aretypically not associated with vaginal wall dryness and generally can beeffectively used for longer periods of time relative to a tampon.However, relative to tampons, menstrual cups are typically moredifficult to insert, can be messy to remove from the user, and typicallydo not accommodate an individual user's particular anatomy very well.

Suffice it to say, there are no devices currently available that providethe comfort, familiarity, and ease of insertion and removal of a tamponcombined with the extended duration of use and/or fluid retentioncapacity of a menstrual cup.

SUMMARY OF THE DISCLOSURE

According to an aspect of the present invention, a menstrual device isprovided that includes a frame and a fluid barrier seal. The frame has aside wall with an exterior surface. The side wall extends between aproximal end and a distal end. In some embodiments, the frame has aninterior surface that at least in part defines an interior cavity. Thefluid barrier seal (i.e., a layer or a coating) is disposed on theexterior surface of the side wall. In such embodiments, the interiorcavity enables the collection and storage of more viscous fluids such asmenses. The fluid barrier seal layer is disposed on the exterior surfaceof the side wall. The menstrual device is configurable in a compactconfiguration and in an expanded configuration. The expandedconfiguration can be an at-rest configuration or a deployedconfiguration. In an expanded configuration, the menstrual device isable to collect and store fluid and as such, has a storage volumegreater than zero. In an expanded configuration, in embodiments havingan interior cavity, the interior cavity has a volume greater than zero.

In some embodiments, the frame is an absorbent material, having apredetermined shape. In some embodiments, the frame is a flexible yetresilient material that assists in providing structure.

According to another aspect of the present invention, a menstrual deviceincludes a frame having a support element that forms at least portionsof the side wall. The side wall extends between a proximal end and adistal end. In some embodiments, the frame includes a support elementand an absorbent material for the collection and storage of fluid. Insome embodiments, the frame has an interior surface at least in partdefines an interior cavity. In such embodiments, the interior cavityenables the collection and storage of more viscous fluids such asmenses. In further embodiments having a support element, the menstrualdevice further includes the fluid barrier seal layer is disposed on theside wall thereby defining at least portions of the exterior surface ofthe menstrual device. In some embodiments, a single material can act asthe fluid barrier seal layer and/or the support element.

According to another aspect of the present invention, a menstrual devicesystem is provided that includes the aforementioned menstrual device andan applicator. The applicator has an insertion tip end, a barrel regionand a finger grip region defined by a plunger end. The applicator has aplunger that telescopically engages the interior of the applicatorbarrel and interacts with the menstrual device. The applicator isconfigured to receive the menstrual device and retain the menstrualdevice in a compact configuration. Prior to being loaded into theapplicator, the menstrual device is in an at-rest configuration. Uponinsertion into the body, the applicator (via the plunger exerting aforce at the distal end of the menstrual device) ejects the menstrualdevice into the body such that the menstrual device expands (i.e. is inan expanded configuration)

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a diagrammatic angled view of a menstrual device embodimentaccording to the present disclosure.

FIG. 1A is a diagrammatic lengthwise sectional view of the menstrualdevice embodiment shown in FIG. 1.

FIG. 1B-1D are diagrammatic axial sectional views of the menstrualdevice embodiment shown in FIG. 1.

FIG. 1E is a diagrammatic lengthwise sectional view of the menstrualdevice embodiment shown in FIG. 1, shown in a slightly compressedconfiguration.

FIG. 2 is a diagrammatic view of a menstrual device according to thepresent disclosure shown in a compact configuration.

FIG. 3A is a diagrammatic angled view of a menstrual device embodimentaccording to the present disclosure.

FIG. 3BA is a diagrammatic lengthwise sectional view of the menstrualdevice embodiment shown in FIG. 2.

FIG. 4A is a diagrammatic angled view of a menstrual device embodimentaccording to the present disclosure.

FIG. 4BA is a diagrammatic lengthwise sectional view of the menstrualdevice embodiment shown in FIG. 3.

FIG. 5A is a diagrammatic angled view of a menstrual device embodimentaccording to the present disclosure.

FIG. 5B is a diagrammatic lengthwise sectional view of the menstrualdevice embodiment shown in FIG. 4.

FIG. 6 is a diagrammatic angled view of a menstrual device embodimentaccording to the present disclosure.

FIG. 7 is a diagrammatic angled view of a menstrual device embodimentaccording to the present disclosure.

FIG. 8A is a diagrammatic side view of a menstrual device embodimentaccording to the present disclosure.

FIG. 8B is a diagrammatic lengthwise sectional view of the menstrualdevice embodiment shown in FIG. 8A.

FIG. 9A is a diagrammatic side view of a menstrual device embodimentaccording to the present disclosure.

FIG. 9B is a diagrammatic lengthwise sectional view of the menstrualdevice embodiment shown in FIG. 9A.

FIG. 10A is a diagrammatic angled view of a menstrual device embodimentaccording to the present disclosure.

FIG. 10B is a diagrammatic lengthwise sectional view of the menstrualdevice embodiment shown in FIG. 10A.

FIG. 11 is a diagrammatic angled view of a menstrual device according tothe present disclosure.

FIG. 12 is a diagrammatic angled view of a menstrual device embodimentaccording to the present disclosure.

FIG. 12A is a diagrammatic lengthwise sectional view of a menstrualdevice embodiment like that shown in FIG. 12, illustrating a supportelement embodiment.

FIG. 12B is a diagrammatic lengthwise sectional view of a menstrualdevice embodiment like that shown in FIG. 12, illustrating a supportelement embodiment.

FIG. 12C is a diagrammatic lengthwise sectional view of a menstrualdevice embodiment like that shown in FIG. 12, illustrating a supportelement embodiment.

FIG. 12D is a diagrammatic lengthwise sectional view of a menstrualdevice embodiment like that shown in FIG. 12, illustrating a supportelement embodiment.

FIG. 13 is a diagrammatic lengthwise sectional view of a menstrualdevice embodiment according to the present disclosure.

FIG. 14 is a diagrammatic lengthwise sectional view of a menstrualdevice embodiment according to the present disclosure.

FIG. 15 is a diagrammatic angled view of a menstrual device embodimentaccording to the present disclosure.

FIG. 15A is a diagrammatic angled view of a menstrual device embodimentaccording to the present disclosure.

FIG. 16 is a diagrammatic side view of a menstrual device embodimentaccording to the present disclosure, where the dashed lines representaxes and internal features.

FIG. 17 is a diagrammatic side view of a menstrual device embodimentaccording to the present disclosure, where the dashed lines representthe lengthwise axis.

FIG. 18 is a chart describing the ejection force during the ejectionprocess of a menstrual device embodiment according to the presentdisclosure.

FIG. 19 is a diagrammatic view of system having an applicator andmenstrual device according to the present disclosure.

FIGS. 20A-D are radiographic images of a menstrual device according toto the present disclosure.

FIGS. 21A-C are radiographic images of a commercially available tamponpledget

FIG. 22 is a chart describing the expansion diameter and radial forceexerted by a menstrual device of the present disclosure.

DETAILED DESCRIPTION OF THE DISCLOSURE

Referring to the drawings, according to an aspect of the presentdisclosure a menstrual device 10 is provided that includes a frame 12and at least one removal element 14. The menstrual device 10 and frame12 provide for the collection of fluids. “Collecting” or “collection”and other tenses as used throughout the present disclosure, is definedas the ability to collect fluids within the menstrual device 10 byeither retaining fluids and/or absorbing fluids. The term “absorbing” or“absorbent” and other tenses as used throughout the present disclosure,is defined as a porous material having the ability to hold fluids insidea material's matrix, such that fluid ingratiates the material'sstructure and/or resides within pores or interstitial voids between thematerial's structure. The term “retain” or “retention” and other tensesas used throughout the present disclosure, is defined as the ability tohold fluid within the device like, for instance, a cup.

In some embodiments, the menstrual device 10 and frame 12 provide forthe retention of fluids. In some embodiments, the menstrual device 10may also include an absorbent material 16 (see FIGS. 4 and 4A) and/or anabsorbent article 18 (see FIGS. 5 and 5A).

Referring to FIGS. 1, 3A-5B, embodiments of the present menstrual device10 include a frame 12 having at least one side wall 20, a distal end 22,a proximal end 24, an interior cavity 26, and a seal layer 28. The sidewall 20 has a thickness 30 extending between an interior surface 32 andan exterior surface 34. The proximal end 24 has a proximal end surface36. In some embodiments (e.g., see FIGS. 1, 1A, 2, 2A, 4, and 4A), thedistal end 22 includes an interior surface 38 and an exterior surface40, and a thickness 42 that extends there between. The distal end 22 ofthe frame 12 is closed; e.g., the interior cavity 26 is not accessiblethrough the distal end 22 (i.e., is fluid impermeable at the distal end22). The proximal end 24 of the frame 12 may be described as being“open” in an expanded configuration (as will be described below) in thatthe interior cavity 26 is accessible through the proximal end 24 of theframe 12; e.g., open to allow the collection of menstrual fluids withinthe interior cavity 26.

To facilitate the description herein, the menstrual device 10 will bedescribed herein as having a lengthwise axis 44 that extends along anX-axis, a widthwise axis 46 that extends along a Y-axis, and a depthwise48 axis that extends along a Z-axis (see FIGS. 1 and 1A). As will bedescribed below, the menstrual device 10 may assume a variety ofdifferent geometric shapes. In each of these shapes, the menstrualdevice 10 (and therefore the frame 12) may assume a plurality ofconfigurations; e.g., a “compact configuration”, a “deployedconfiguration”, and an “at rest configuration”. The particular geometricshape of a menstrual device is visible when the menstrual device is its'“at rest configuration”. To facilitate description of these differentmenstrual device geometric shapes, as well as the respectiveconfigurations of each, the menstrual device 10 (and therefore the frame12) may be described as having a cross-sectional area (i.e., in the Y-Zplane). Depending on the particular geometric shape of the menstrualdevice 10, in the deployed and at rest configurations, thecross-sectional area of the menstrual device 10 may differ at differentlengthwise positioned sections (e.g., see sectional views 1B-1B, 1C-1C,1D-1D, etc.; e.g., a truncated conical shaped device as shown in FIGS. 1and 1A), or the cross-sectional area may be equal at differentlengthwise positioned sections (e.g., a tubular shaped device as shownin FIGS. 3A and 3B).

A menstrual device 10 configured in a “compact configuration” is shownin FIG. 2. The term “compact configuration” as used herein refers to aconfiguration wherein the frame 12 of the menstrual device 10 iselastically deformed (e.g., by squeezing, compressing, or folding theframe 12) to an extent wherein the interior cavity 26 has a volume lessthan is present in a deployed configuration. “Elastic” as used herein,describes strain a material can recover from, contrasted to strain thatcauses the material to plastically deform. In some instances when themenstrual device 10 is in a compact configuration, the interior cavity26 has a “zero” value cavity volume; e.g., the side wall interiorsurfaces 32 come together with no volume there between, or saiddifferently, the cavity is obfuscated. As will be evident from thedescription below, in some embodiments the frame 12 may be elasticallydeformed (e.g., compressed) to not only have a zero interior cavity 26volume, but also the frame 12 may be elastically deformed further toassume a lesser volume; e.g., a configuration having a zero interiorcavity 26 volume and compressed side walls. In some instances when themenstrual device 10 is in a compact configuration, the interior cavity26 has a volume (e.g., the side wall interior surfaces 32 do notcompletely come together), but that volume is less than the interiorcavity 26 would have in a deployed configuration. To facilitate thedescription of the present menstrual device 10, a menstrual device 10 ina compact configuration may be described as occupying a first volume.

A menstrual device 10 in a “deployed configuration” can be seen in FIG.1E. In the deployed configuration, the menstrual device 10 is in apartially compressed configuration; i.e., assuming a volume less thanthe volume of the same device at rest, but more volume than the samedevice in a compact configuration. FIG. 1E diagrammatically shows forcesacting on the exterior surface 34 of the device 10 that cause the deviceto be in a slightly compressed configuration; i.e., a deployedconfiguration. The term “deployed configuration” refers to a menstrualdevice 10 configuration that may be assumed under normal use conditions;e.g., a configuration that may be typically assumed during use of thedevice when the device 10 is located in its intended functionalposition. In a deployed configuration, menstrual device 10 embodimentsthat include an interior cavity 26: a) have an interior cavity 26 volumegreater than zero (e.g., at least some side wall interior surface 32portions are separated from one another to create a greater than zerovolume there between); and b) have an interior cavity 26 that is open(i.e., accessible) at the proximal end 24 of the frame 12. The menstrualdevice 10 in a deployed configuration has less than or equal to onehundred percent (100%) of the “at rest” configuration's dimensionsand/or volume. The menstrual device 10 in a deployed configuration canbe described as occupying a second volume that is greater than a firstvolume.

A menstrual device 10 in an “at rest” configuration is shown in FIGS. 1,3A, 4A, and 5A. The term “at rest” as used herein refers to theconfiguration a menstrual device 10 assumes by itself (i.e., expands to)when no external forces are applied to the menstrual device 10,therefore the device 10 is at rest and geometrically stable (e.g., noapplied forces acting on the device 10 that prevent the frame 12 fromfurther expanding). In an at rest configuration, device 10 embodimentshaving an interior cavity 26 will have an interior cavity volume greaterthan zero. In an at rest configuration, the interior cavity 26 is openaccessible) at the proximal end 24 of the frame 12. In an at restconfiguration the menstrual device can be described as having a thirdvolume that is greater than the first volume, and/or greater than orequal to the second volume.

The frame 12 is configured such that in the absence of applied forcesholding the frame 12 in a compact configuration, the frame 12 will byitself elastically change from a compact configuration to a deployedconfiguration (i.e., where some amount of applied forces are stillapplied to the device 10 that prevent the device 10 from completelyexpanding to an at rest configuration), or will completely elasticallyexpand to an at rest configuration (e.g., the configurationindependently assumed in the absence of forces applied to the device10).

The ability of the frame 12 to elastically expand (e.g., from a compactconfiguration to a deployed configuration or an at rest configuration)does not utilize any liquid (absorbed or otherwise incorporated into theframe 12) as a mechanism of change. In some embodiments, the elasticexpansion of the frame 12 is accomplished by the frame 12 unfolding. Insome embodiments, the elastic expansion of the frame 12 is a function ofthe frame material being inherently elastically expandable between acompressed configuration (e.g., a compact configuration) and an expandedconfiguration (e.g., a deployed configuration or an at restconfiguration). In some embodiments, the ability of the frame 12 toelastically expand may be a combination of these mechanisms, or othermechanisms.

In some embodiments, the interior cavity 26 and therefore the volume ofthe interior cavity 26 is completely defined by the interior surface 32of the side wall 20 (e.g., see FIGS. 4A and 4B). In those embodimentswhere the distal end 22 of the frame 12 includes an interior surface 38and an exterior surface 40 (e.g., see FIGS. 1, 1A, 3A, 3B, 5A, and 5B),the interior cavity 26 (and its volume) is defined by the interiorsurface 32 of the side wall 20 and the interior surface 38 of the distalend 22.

The frame 12 comprises one or more materials, which collectively havemechanical material properties that enable the frame 12 to: a) beelastically deformed or folded into a compact configuration; and b) inthe absence of applied forces holding the frame 12 in a compactconfiguration, self-expand into an expanded configuration; e.g., withoututilizing any liquid (absorbed or otherwise incorporated into the frame12) as a mechanism of change. An example of an acceptable frame materialis an elastic polymer that can be formed into a geometric shape usefulfor a menstrual device 10; e.g., an elastic polymer formed to assume adesired geometric shape and volume in an at rest configuration (i.e., inthe absence of applied forces) and which polymer can be elasticallycompressed to a smaller volume and thereby assume a reduced volumeconfiguration (e.g., a deployed configuration or a compactconfiguration). Specific non-limiting examples of elastic polymersinclude medical grade and/or biocompatible polyester, polyvinyl alcohol(PVA), polypropylene, polyacrylate, or polyurethane foams such asaliphatic that resist changes in color and/or aromatic, and/orstarch-based foams such as those made from crosslinked polysaccharides.The term “foam” as used herein refers to a substrate construction havinginternal voids, which voids may vary in size and number per volumetricunit.

The mechanical material properties of the frame material(s) that enablethe frame 12 to elastically expand from a compact configuration to anexpanded configuration may be described in terms of “expansion forces”.To illustrate, consider a frame 12 maintained in a deployedconfiguration (e.g., see FIG. 1E, wherein the menstrual device 10assumes a volume less than the volume of the same device in an at restconfiguration). Body wall surfaces 50 (e.g., vaginal wall surfaces) incontact with the menstrual device 10 to potentially prevent themenstrual device 10 from assuming its fully expanded configuration (i.e.the at-rest configuration), and thereby maintain the menstrual device 10in the partially compressed deployed configuration. The vaginal cavityis known to typically exert a pressure between about 0.25 psi and about1.0 psi. As a result, the expansion forces 51 that would otherwise causethe menstrual device 10 to elastically expand to an at restconfiguration, now act against the body wall surfaces 50. Thoseexpansion forces 51, which are quantifiable, are at least a part of themechanism that enables the menstrual device 10 to be maintained at aparticular position within the user's vagina. It should be noted fromthe above that menstrual devices 10 according to the present disclosureare intended to assume an expanded configuration, albeit one that ispotentially partially compressed configuration (i.e. a deployedconfiguration), during in vivo use. The expansion forces 51 aredescribed as being “at least part of the mechanism” that enables thedevice to be positionally retained because other factors may also play apart in retaining the device; e.g., the coefficient of friction of theexposed surface of the seal layer 28, the coefficient of friction of thebody wall surface 50, the geometric shape of the menstrual device 10,etc. For the present menstrual device embodiments, the frame 12 ischosen to have mechanical material properties (as described above) thatproduce expansion forces adequate to retain the device 10 in vivo in adeployed configuration, while at the same time such expansion forces 51are below a magnitude that: a) would cause user discomfort; b) inhibitor prevent the menstrual device 10 from being placed in a compactconfiguration (e.g., for insertion purposes with or without anapplicator); and/or c) inhibit removal of the menstrual device 10 froman in vivo deployment. The expansion forces 51 produced by the framematerial are further discussed below in the context of an applicatordevice that may be used with the present menstrual device 10.

As indicated above, the frame 12 (and therefore the menstrual device 10)may assume a variety of different geometric shapes three-dimensionallyand/or in profile or cross-section (i.e. cup-like, conical, tubular,funnel-shaped, tapered and/or shaped), all of which shapes include theinterior cavity 26. FIGS. 1 and 1A, for example, show a frame 12 in anenlarged configuration having a truncated conical shape. FIGS. 3A and 3Bshow a frame 12 in an enlarged configuration having a tubular shape.FIGS. 4A and 4B show a frame 12 in an enlarged configuration having aconical shape. In some embodiments as those exemplified in at leastFIGS. 3A and 3B, the menstrual device has symmetry about its verticalaxis (i.e. X axis). FIGS. 5A and 5B show a frame 12 in an enlargedconfiguration having a widthwise dimension that is non-linearly variablealong the length of the device. The present menstrual device 10 is notlimited to these particular geometric shapes. In FIGS. 1, 1A, 3A, 3B,4A, 4B, 5A, and 5B, the frame 12 is shown as being symmetrical withinthe Y-Z plane; i.e., the Y and Z dimensions are identical or nearlyidentical. In alternative embodiments, the present menstrual device 10may have a geometric shape that is non-symmetrical in the Y-Z plane;e.g., the width dimension (i.e., the Y direction) may be greater thanthe depth dimension (i.e., the Z direction); e.g., an oval shape. Inaddition, or alternatively, the geometric shape may be non-symmetricalalong its length; e.g., cross-sectional Y-Z plane geometries may vary atdifferent lengthwise positions. For example, the geometric shape of theframe 12 may be customized for in-vivo placement for enhanced sealingperformance; e.g., shaped to have a geometric shape that conforms with aparticular shape associated with a vaginal region where the device isintended to be deployed.

As indicated above, menstrual devices 10 according to the presentdisclosure are intended to assume an expanded configuration (e.g., adeployed configuration), albeit one that is potentially partiallycompressed, during in vivo use; it is possible the menstrual device 10could be fully expanded about a portion or a region, and/or fullyexpanded, as anatomy of the vaginal canal varies. Nonetheless, based onin vivo testing identifying anatomical features, dimensions, it islikely the menstrual device 10 will be partially compressed during invivo use. The expansion forces associated with the partially compressedmenstrual device 10 create a seal between the side wall exteriorsurfaces of the device and the user body wall surfaces 50. The aforesaidseal helps to prevent fluid passage between the side wall exteriorsurface and the user body wall surface 50 during use. In all menstrualdevice 10 embodiments having an interior cavity 26, the geometric shapeof the frame 12 is such that when the device is deployed in vivo in itsoperational position, the interior cavity 26 of the frame 12 is open atthe proximal end 24 to enable the interior cavity 26 to receive andcollect menstrual fluids. It is recognized that during use, movement ofthe user may cause the present menstrual device 10 to deflect andpotentially assume a variety of different geometric shapes. As such, insome user physical positions it is possible that the present menstrualdevice 10 may be compressed; e.g., into a configuration wherein theinterior cavity 26 is not open at the proximal end 24. Nevertheless, thestatement above regarding the interior cavity 26 of the frame 12 beingopen (when deployed in vivo in its operational position) reflects thatthe interior cavity 26 of the frame 12 is open at the proximal end 24during most but not necessarily all possible user positions.

The frame 12 may be manufactured using a variety of differenttechniques. An acceptable example of such a technique is polymer moldingtechnique wherein the frame 12 is molded to have the desired geometricconfiguration. Molding is particularly useful when the frame 12 isformed from an elastic polymer foam.

The menstrual device 10, in an at rest configuration, has a length alongits lengthwise axis of between about 1.0 inches (25.4 mm) and about 2inches (51 mm), and more preferably between about 1.5 inches (38 mm) and1.75 inches (44.5 mm). In some embodiments, the length of the menstrualdevice is about 1.5 inches 1.6 inches or about 1.75 inches. For clarity,the length of the menstrual device 10 is from its proximal end 24 to itsdistal end 22 defining the fluid collection portion of the device; itdoes not include any additional length of the removal element 14.

The menstrual device 10, in an at rest configuration, has a proximal end24 width dimension along the widthwise axis of between about 1.0 inches(25.4 mm) and about 2 inches (51 mm), and more preferable between about1.5 inches (38 mm) and 1.75 inches (44.5 mm). In some embodiments, thewidth of the menstrual device at the proximal end is about 1.5 inches1.6 inches or about 1.75 inches.

The menstrual device 10, in an at rest configuration, has a proximal end24 depth dimension along the depthwise axis of between about 1.0 inches(25.4 mm) and about 2 inches (51 mm), and more preferable between about1.5 inches (38 mm) and 1.75 inches (44.5 mm). In some embodiments, thedepth of the menstrual device at the proximal end is about 1.5 inches1.6 inches or about 1.75 inches.

In some embodiments of the menstrual device 10 in an at restconfiguration, the ratio between the length and the width at theproximal end 24 is greater than 1. In other embodiments, the ratio isbetween about 1 and about 2. In other embodiments, the ratio between thelength and the width at the proximal end 24 is greater than 1. In otherembodiments, the ratio is between about 1 and about 2.

The menstrual device 10, in an at rest configuration, has a distal end22 that has less than or equal to the widthwise and/or depthwisedimension of the proximal end 24. For instance, the widthwise dimensionand/or depthwise dimension at the distal end 22 is between about 0.1inches (0.25 mm) to about 1.5 inches (38 mm). In some embodiments, theratio of the widthwise dimension and/or depthwise dimension at theproximal end 24 to the widthwise dimension and/or depthwise dimension atthe distal end 22 is between about 20:1 and 1:1. In some embodiments,this ratio is between about 10:1 and about 1:1. In other embodiments,this ratio is between about 5:1 and about 1.25:1. In furtherembodiments, this ratio is greater than 1. In yet further embodiments,this ratio is less than 2:1. In yet other embodiments, this ratio isabout 1.25:1, about 1.5:1, or about 1.75:1.

In some embodiments, the menstrual device 10, in an at restconfiguration, has a widthwise dimension and depthwise dimension, at anygiven cross-sectional slice in the Y-Z plane, have a ratio between thewidthwise dimension and the depthwise dimension of about 1:1.Nonetheless, in a deployed configuration, this ratio may change and bebetween 1:2 and 2:1 depending on the anatomical geometry of a givenuser. This widthwise/depthwise ratio can be dynamic as the menstrualdevice 10 collects fluid and/or as the user moves through a variety ofpositions, and/or other changes the body undergoes over time throughouta given period of time when the menstrual device 10 is worn (i.e., whichcan be for several hours).

The cavity 26, in the at-rest configuration, has a length dimensionalong the lengthwise axis of between about 0.1 inches (2.5 mm) and about1.9 inches (48 mm), or between about 0.2 inches (5 mm) and about 1.75inches (44.5 mm), or between about 0.25 inches (6.5 mm) and about 1.25inches (32 mm). In some embodiments, the cavity 26 has a lengthdimension that is less than half of the length of the menstrual device10, or said differently, the ratio of the length of the cavity 26 to thelength of the menstrual device is less than or equal to 1:2. In someembodiments, this is preferred in order to maintain resiliency in thedevice sufficient to go from a compact configuration to a deployedconfiguration such that the deployed configuration is able to exert apressure against the vaginal wall to create a sufficient seal therebymitigating leakage, albeit a pressure that is not otherwiseuncomfortable or noticeable to the user.

FIG. 22 demonstrates how the dimensions of the menstrual device 10provide varying expansion profiles. Specifically, FIG. 22 describesradial pressure (psi) exerted by menstrual device 10 as a function ofthe level of radial compaction of the menstrual device as described inthe title (reference numeral 308). The horizontal axis 310 describes thediameter of the menstrual device in mm, while the vertical axis 312describes the radial force in psi. Three samples having a frame materialincluding AQUAZONE 4 lb foam made by FXI were tested, where the highestcurve labeled “302” regards a menstrual device that is 1.75 inches inlength, with a cavity having a length of 0.25 inches, the middle curvelabeled “304” regards a menstrual device that is 1.75 inches in length,with a cavity having a length of 0.50 inches, and the lowest curvelabeled “306” regards a menstrual device that is 1.50 inches in length,with a cavity having a core that is 0.50 inches in length. If one readsFIG. 22 from right to left, one notes the diameter in the at-restconfiguration of the three samples. Moving towards the vertical axis(i.e., from right to left), one sees each of the three samplesundergoing radial compression, and as the compressive force is applied(thereby reducing the diameter of each sample) a force is exerted. The1.75 inch sample with the shallowest cavity provided the greatest amountof resistance to compression (or the ability to apply the greatestradial pressure of the samples), while the 1.5 inch sample with a deepercavity provided the least amount of resistance (or the ability to applythe lowest radial pressure of the samples). Nonetheless, the datademonstrates the menstrual device 10 of the present disclosure providesa radial pressure that assists in creating a seal with the vaginal wallof at least 0.3 psi, enough to provide an opposite force of similarmagnitude to that of the vaginal wall. In some embodiments, a pressureof at least 0.50 psi is provided, and in further embodiments, a pressureof at least 1.00 psi is provided. In some embodiments, the menstrualdevice 10 of the present disclosure is able to provide a pressure of atleast 0.25 psi with a deployed configuration diameter of at least 31 mm(or 70% of its at-rest diameter).

In some embodiments, it is preferred to have a cavity 26 having a lengthdimension that is greater than 0.25 inches due to the relatively slowfluid penetration times of the frame 12 material, as measured by a highspeed camera, distilled water, and a goniometer such as Model DSA100made by Kruss, having a needle providing a 55 ml drop size where theneedle tip is positioned a distance of 9 mm from the proximal end 24 ofthe menstrual device 10. For instance, a 1″ by 1″ cubic sample ofAQUAZONE foam material (density of 4 pounds) made by FXI has a fluidpenetration time that is about four times slower than a regularabsorbency tampon branded TAMPAX PEARL made by Procter & Gamble,demonstrating some embodiments of the menstrual device 10 of the presentdisclosure have a frame 12 with distinct fluid handling characteristicsthan that of typical tampon pledgets made of rayon, cotton, or the like.As such, the cavity 26 provides a reservoir to retain fluid and increasethe exposed surface area of the frame 12 while permitting the frame 12to absorb fluid. In some embodiments, the ratio of the exposed surfacearea provided by the cavity 26 versus the surface area of just theproximal end 24 (in embodiments without a cavity) is between about 2.5:1to about 1:1, or is greater than 1:1, or is less than 2:1, or is about1.2:1.

In some embodiments such as those shown in FIG. 3A and 3B, the cavity 26is a single lengthwise cavity that is generally tubular such that thewidthwise and/or depthwise dimension at the proximal end 24 is aboutequal to the widthwise and/or depthwise dimension at the distal end 22.In other embodiments such as those demonstrated in FIGS. 4A-5B, thecavity 26 has a taper such that the cavity 26 has a greater widthwiseand/or depthwise dimension at the proximal end 24 than at the distal end22. The cavity 26 has a ratio of the widthwise and/or depthwisedimension at the proximal end 24 to the widthwise and/or depthwisedimension at the distal end 22 is between about 20:1 and 1:1. In someembodiments, this ratio is between about 10:1 and about 1:1. In otherembodiments, this ratio is between about 5:1 and about 1.25:1. Infurther embodiments, this ratio is greater than 1. In yet furtherembodiments, this ratio is less than 2:1. In yet other embodiments, thisratio is about 1.25:1, about 1.5:1, or about 1.75:1.

In other embodiments as exemplified in FIGS. 6 and 7, the cavity 7 has astep-change 27 in widthwise and/or depthwise dimension [as one movesalong the length of the menstrual device 10 from a proximal end 24 tothe distal end 22]. For exemplary purposes, the step change 27 is shownby the change in color (i.e., the lighter grey indicates a location 27Aabove step-change 27, and the darker grey indicates a location 27B belowthe step-change 27). The step-change 27 in widthwise and/or depthwisedimension describes an abrupt change in such dimension (i.e. not agradual taper). In some embodiments having a single cavity 26 above thestep change 27 to a single cavity 26 below the step change 27 (i.e. asexemplified in FIG. 6 and/or with respect to one of the four cavities26A, 26B, 26C, and/or 26D in FIG. 7), the cavity 26 has a ratio of thediameter of the widthwise and/or depthwise dimension at a location 27Aimmediately above the step change 27 of to the widthwise and/ordepthwise dimension at a location immediately below 27B the step change27 of between about 30:1 to about 2:1, or between about 25:1 to about5:1, or between about 15:1 to about 8:1.

In other embodiments, a step-change 27 in widthwise and/or depthwisedimension [as one moves along the length of the menstrual device 10 froma proximal end 24 to the distal end 22] involves a change in the numberof cavities. As exemplified in FIG. 7, cavity 26 becomes four cavities26A-26D. The number of cavities 26 can vary from one to a plurality,keeping in mind typical cavities are at least 0.1 inches (in a minimumwidthwise and/or depthwise dimension if the cavity is not constant alongthe lengthwise axis) and up to about 0.9 inches (in a maximum widthwiseand/or depthwise dimension if the cavity is not constant along thelengthwise axis) in widthwise and/or depthwise dimension and need to bespaced apart to ensure the cavities do not collapse upon each other. Inone embodiment, the ratio of the surface area of the cavity 26immediately above 27A the step-change 27 to the surface area of thecavity (or all cavities) 26 immediately below 27B the step-change 27 isbetween about 18:1 and 2:1, or less than or equal to about 10:1, orgreater than or equal to about 2:1.

In embodiments having a single cavity 26 immediately above 27A astep-change 27 and at least two cavities (i.e. 26A, 26B) immediatelybelow 27B the step-change 27, the ratio of the surface area of thecavity 26 immediately above 27A the step-change 27 to the surface areaof the cavities (i.e. 26A, 26B) below 27B the step-change 27 is betweenabout 18:1 and 1:1, or between about 10:1 and 1.5:1, or less than about10:1, or greater than about 1.1:1.

Another aspect of the menstrual device 10 of the present disclosure isthat it is distinct from commercially available internally wornmenstrual devices in where fluid collects first. As with commerciallyavailable tampon pledgets, fluid is typically absorbed into the pledgetat the top region of the pledget (i.e. the proximal end) and travelsdownward towards the bottom of the pledget. In other words, commerciallyavailable pledgets absorb fluid in the top region first, and fluidthereafter travels downward. Commercially available menstrual cups actoppositely. Fluid is retained within the menstrual cup and pools at thebottom and fills upward. The menstrual device of the present disclosurecollects fluid differently, in part due to the fact that it collectsfluids. In embodiments with cavities, the fluid collects in the middleregion of the pledget (i.e. not solely at the proximal surface of atampon pledget, and not solely by filling from the bottom-up of themenstrual cup). In embodiments where the cavity 26 (or cavities 26) havea length that is at least about 10% and up to about 90% of the length ofthe menstrual device 10, the fluid will initially collect to a middleregion. As it collects in the middle region, fluid travels downwardlyand outwardly from where the fluid is being directed into the menstrualdevice 10 as the frame 12 (absorbent layer 19, and/or absorbent article18, as discussed below) absorbs fluid. As the frame 12 (absorbent layer19, and/or absorbent article 18, as discussed below) absorbs fluid andmeets its gram per gram capacity, the fluid is collected upwardly andoutwardly. If the length of the cavity 26 (or cavities) exceeds 75% ofthe length of the menstrual device 10, the fluid will collect from thebottom region upward.

Fluid collection for a menstrual device 10 embodiment is exemplified byFIGS. 20A-20D, and is generated by micro-CT scanning using aradiotransparent test fixture applying a 0.25 psi pressure to simulatein-body pressures (note: the test fixture in FIGS. 20A-20D is dark grey,contrasted with menstrual device 10 seen as a lighter grey, and thefluid is seen as black, or darker than the text fixture and menstrualdevice 10). This test apparatus and methodology is described more fullyin U.S. Patent Application Publication No. 2017/0135876 titled“Four-Dimensional Analysis System, Apparatus, and Method” which isincorporated by reference in its entirety. The menstrual device 10 isplaced within a condom (or other fluid impermeable material/membrane;seen in FIGS. 20A-D in white surrounding menstrual device 10) with aline transmitting fluid placed directly above the proximal end 24 andcentered over cavity 26 (the tip of the needle on the line is shown asthe white moon-shaped feature at the top of each FIG. 20A-20D). Fluid ispumped at a controlled rate into the menstrual device 10 (shown in grey)over time (“t”), as demonstrated by FIGS. 20A-20D at exemplary timest=134 seconds, t=937 seconds, t=1205 seconds, and t=1370 seconds,respectively. As demonstrated by the figures, the middle region of themenstrual device 10 collects fluid, distributing fluid downward towardsdistal end 22, radially outward, and thereafter collects upward untilthe entire menstrual device volume is exhausted.

FIGS. 21A-21C demonstrate how commercially available tampon pledgetsabsorb fluid, in the aforementioned test apparatus with the same set-up,having exemplary times t=55 seconds, t=110 seconds, and t=386 seconds,respectively. As shown, commercially available tampons absorb fluidtop-down.

In any embodiment, the compact configuration dimensions are less thanthe aforementioned dimensions in the at-rest configuration. In anyembodiment, the deployed configuration dimensions can be up to or equalto the aforementioned dimensions in the at-rest configuration. Asdiscussed above, these dimensions take into account various parametersincluding typical length, depth and width of the vaginal canal, pressureexerted by the vaginal canal, collection capacity meeting or exceedingexisting internally worn menstrual devices such as cups and tampons, andmitigating against leakage and vaginal irritation such as dryness causedby commercially available rayon/cotton tampon products.

The seal layer 28 is disposed on at least a portion of the exteriorsurface 34 of the side wall 20. In those embodiments wherein the frame12 includes a distal end exterior surface 40, the seal layer 28 is alsodisposed on the distal end exterior surface 40.

In some embodiments, the seal layer 28 is disposed on only a portion ofthe exterior surface 34 of the side wall 20; i.e., the seal layer 28extends from the distal end 22 toward, but not completely to, theproximal end 24; e.g., see FIGS. 1 and 1A. In some of these embodiments,the seal layer 28 is impermeable and as such, to increase the amount ofsurface area of the frame 12 that can collect fluid (and thus helpmitigate against leakage), a portion of the frame 12 is not covered bythe seal layer 28. In some embodiments, the length of the exteriorsurface 34 of side wall 20 that is not covered by the seal layer 28 isup to 75% of the total length of the menstrual device 10, or up to 50%,up to 35%, or greater than 10%. In some embodiments, the length of theexterior surface 34 of side wall 20 that is not covered by the seallayer 28 is between about 10% and about 35%.

In some embodiments, the seal layer 28 is disposed on the entirety ofthe exterior surface 34 of the side wall 20; i.e., the seal layer 28extends from the distal end 22 all the way to the proximal end 24; e.g.,see FIGS. 3A, 3B, 5A, and 5B. In some embodiments, the seal layer 28 isdisposed on both the entirety of the exterior surface 34 of the sidewall 20, and also covers at least a portion of the proximal end surface36; e.g., see FIGS. 4A, 4B, and FIG. 15A. In embodiments where the seallayer 28 is disposed on the proximal end surface 36, the seal layer 28covers up to 50% of the proximal end surface, up to 35%, up to 25%, orup to 10%.

The seal layer 28 comprises one or more materials that collectively donot appreciably absorb fluid. In some embodiments, the seal layer 28does not appreciably allow fluid to pass through the seal layer 28 andinto the frame 12. For these embodiments, the seal layer 28 is acontinuous, non-perforated layer that prevents the passage of fluidthere through. Hence, the seal layer acts as a fluid barrier. As will bedescribed below, in some embodiments the seal layer 28 may includeperforations that allow a limited amount of fluid transfer across theseal layer 28 such that it may be stored, retained and collected inmenstrual device 10, but mitigate against fluid travelling across theperforated seal layer and out of the menstrual device 10 (i.e. bycapillary action). In some embodiments, seal layer 28 is hydrophobic.

The seal layer 28 may be comprised of a variety of different types ofmaterials and is not therefore limited to any particular type ofmaterial provided such material(s) is capable of functioning as a fluidbarrier. Examples of acceptable seal layer 28 materials include moldedor thermoformed polymers, flexible films, hydrophobic nonwovenmaterials, nylon, silicone, polyacrylate, polyurethane, polypropylene,polyethylene and other inert olephins. Preferably any such material isprovided in a form that is medical grade and/or biocompatible. Someexemplary films are those made by Bayer, Vancive or Bemis (i.e. BemisST-104, Bemis ST-804, Bayer VPT 9074). As will be described in moredetail below, the seal layer 28 functioning as a fluid barrier (inparticular those embodiments where the seal layer 28 provides a completefluid barrier) provides several advantages. For example, because theseal layer 28 does not permit fluid transfer from a vaginal wall (i.e.,the wall the device is in contact with) into the menstrual device 10,the seal layer 28 prevents the migration of menstrual fluids or otherbody fluids away from the vaginal wall. As a result, the menstrualdevice 10 is less apt to be associated with undesirable, potentiallyirritating, vaginal wall dryness. In this regard, it can be seen thatthe present menstrual device 10 does not function as a tampon typicallyfunctions. As another example, the seal layer 28 functioning as a fluidbarrier also enables the frame 12 to collect and retain menstrualfluids; e.g., menstrual fluids collected within the interior cavity 26of the menstrual device 10 are retained within the interior cavity 26.In those embodiments wherein the frame 12 comprises a foam material, theamount of menstrual fluid that can be collected is a function of theinterior cavity volume as well as the porous void volume of the framematerial. Current testing indicates that these menstrual deviceconfigurations can collect and hold up to four times (4×) the volume ofmenstrual fluid prior to leakage as compared with the maximum menstrualvolume a typical tampon pledget can absorb prior to leakage. Inaddition, the length of time a typical tampon pledget can be worn isinfluenced by the volume of fluid it can absorb prior to leakage. Theability of the present menstrual device 10 to collect a substantiallygreater volume of fluid (up to 4×) prior to leakage, significantlyincreases the duration of time the menstrual device 10 can becomfortably worn without leakage.

Experimentation has been done to determine the volume capacity ofvarious embodiments of the present disclosure. Testing has beenperformed with two different set-ups, using, on the one hand, a syngynaapparatus, and on the other, an Ion Simulator. The sygina apparatus useda 1% saline solution [as required by the FDA] and a flow rate of 0.8ml/min, while the Ion Simulator used a synthetic menstrual fluid and aflow rate of 2 ml/min. below chart describes various embodimentsdemonstrating collection up to about four times a regular tampon (i.e.with an absorbency between 6 g and 9 g). The below chart describes thedry weight of the menstrual device versus the amount of fluid (in grams)the menstrual device can collect. Samples with 1.5″ and 2″ lengths weretested, having a 1.75″ proximal end diameter. All embodiments testedhave a seal layer including a biocompatible film.

As demonstrated above in Table 1, varying the geometry of the menstrualdevice 10 has an effect on the g/g absorbency. The above indicates themenstrual device of the present disclosure has a g/g absorption whenusing the aforementioned syngyna set-up, exceeding 5 g/g. or between 5g/g and 7 g/g. Using the aforementioned Ion Simulator methodology, themenstrual device of the present disclosure has a g/g absorptionexceeding 8 g/g, between 8 g/g/ and 11 g/g. Also demonstrated above inTable 1, the menstrual device 10 has an absorbent capacity of at least15 g, or at least 18 g, or at least 22 g, as measured by the syngynaapparatus using a 1% saline solution and a flow rate of 0.8 ml/min.

As exemplified above, by comparing the two different test methodologiesand fluids, on can more readily correlate absorbency information basedon less viscous fluids (i.e. 1% saline) and more viscous fluids (thesynthetic menstrual fluid). The correlation factor of typical syngynafluid to synthetic menstrual fluid is about 0.6. This enablescorrelation between various set-ups and parameters (i.e. In vivo studiesand in vitro studies).

The seal layer 28 may also improve the ease with which the menstrualdevice 10 is ejected from the applicator 52. Due to the menstrual device10 having an at-rest, expanded configuration, ejecting menstrual device10 from applicator 52 can be difficult for the user (i.e. requiring theexertion of a greater amount of force than with known tampons). The seallayer 28 is a smooth and/or slippery material such that its coefficientof friction is less than that of the frame 12 material. As such, seallayer 28, when applied to frame 12, can, in embodiments including anapplicator 52, reduce the ejection force of the menstrual device 10 fromapplicator 52 to be less than 50 ounces, less than about 40 ounces,preferably less than 30 ounces and more preferably, less than or equalto about 20 ounces.

The seal layer 28 may be applied to the exterior surface 34 of the sidewall 20 using a variety of different techniques (e.g., applied as afilm, or as a coating applied by a spray process or a dipping process,etc.), and the seal layer 28 application process is not limited to anyparticular technique. Seal layer 28 materials may be adhered to theframe 12 using an adhesive. Seal layer 28 materials may alternatively beapplied to the exterior surface 34 and subsequently subjected to acuring type process (e.g., elevated temperatures, UV light, etc.) thatcauses the seal layer 28 material to bond or otherwise adhere to theexterior surface 34. In those embodiments wherein the seal layer 28material is formed as a film prior to application to the frame 12, theseal layer 28 film may be applied using a vacuum forming process. Insome embodiments where a film seal layer 28 is used, the film seal layer28 may include a plurality of film sublayers. For example, the film seallayer 28 may include a first sublayer comprised of a first thermoplasticmaterial having a first melt temperature and a second sublayer comprisedof a second thermoplastic material having a second melt temperature,wherein the second melt temperature is lower than the first melttemperature. In this embodiment, the film seal layer 28 is applied tothe frame 12 such that the second sublayer is disposed in contact withthe exterior surface 34 of the side wall 20 and the first sublayer isexposed; i.e., the second sublayer is disposed between the firstsublayer and the side wall exterior surface 34. During the film seallayer 28 application process, the film seal layer 28 is subjected to atemperature at or above the melt temperature of the second sublayer, butbelow the melt temperature of the first sublayer. As a result, thesecond sublayer acts to bond the first sublayer to the frame 12.

As indicated above, in some embodiments the seal layer 28 as describedabove may include perforations that allow a limited amount of fluidtransfer across the seal layer 28. The collective area of theperforations is substantially smaller than the area of the seal layer28. Because the collective perforation area is much smaller than theentire seal layer area, the amount of fluid transfer across the seallayer 28, is minimal. Hence, a perforated seal layer 28 stillpredominantly functions as a fluid barrier. To the extent that there isfluid transfer across the seal layer 28 via the perforations, it isunderstood such fluid transfer is likely to be fluid transfer into themenstrual device 10.

In an alternative embodiment of the present disclosure shown in FIGS.10A and 10B, the menstrual device 10 includes a body 700 defined by atleast one side surface 734, a distal end 722, a proximal end 724, and aseal layer 728. The side surface 734 extends between the distal end 722and the proximal end 724. The proximal end 724 has a proximal endsurface 736. In this embodiment, the menstrual device 10 does notinclude an interior cavity. The distal end 722 may also have a distalend surface 740, depending on the specific geometry of the menstrualdevice 10.

Referring to FIGS. 11 and 12-12D, embodiments of the present menstrualdevice 10 include a support element 17. The menstrual device 10exemplified in FIG. 11, similar to FIGS. 10A and 10B, does not have aninterior cavity. As shown in FIG. 11, the menstrual device 10 includes abody 700 defined by at least one side surface 734, a distal end 722, aproximal end 724, and a seal layer 728. The side surface 734 extendsbetween the distal end 722 and the proximal end 724. The proximal end724 has a proximal end surface 736. In this embodiment, the menstrualdevice 10 does not include an interior cavity.

In some embodiments, the frame 12 includes the support element 17 and anabsorbent element 19. The frame is configured so it can be elasticallydeformed or folded into a compact configuration and can also be expandedinto an expanded configuration, i.e., expanded into a deployedconfiguration or an at rest configuration.

In some embodiments, the support element 17 completely encompasses theabsorbent element 19. The distal end 722 may also have a distal endsurface, depending on the specific geometry of the menstrual device 10.

FIGS. 12-12D provide embodiments including an alternate collectionmeans, having a support member 17, an absorbent element 19 that form aside wall 20, a distal end 22, a proximal end 24, an interior cavity 26,and a seal layer 28. Absorbent element 19 includes materials describedthroughout this application relating to frame 12. Seal layer 28 can beclose-forming around support element 17 and/or absorbent element 19, orcan be loose-fitting like a bag, thereby enabling the support element 17and/or absorbent element 19 to be freely dynamic (i.e. expand upon fluidcollection). For clarity, in embodiments where seal layer 28 is elasticsuch that support element 17 and/or absorbent element 19 are dynamic.

In some embodiments, the support element 17 is configured to elasticallyself-expand; e.g., if radially compressive forces less than thoserequired to hold the support element 17 in a compact configuration areapplied to the support element 17, the self-expanding support element 17will radially expand into a deployed configuration, or if no radiallycompressive forces are applied to the support element 17, theself-expanding support element 17 will radially expand into an at restconfiguration. In the at rest configuration, the self-expanding elementassumes a predetermined geometric shape. The elastically self-expandingsupport element 17 expands without utilizing any liquid (absorbed orotherwise) as a mechanism of change. This type of support element 17 maybe referred to as having an “elastic memory”. In other embodiments, thesupport element 17 does not elastically self-expand, or is incapable byitself of causing the menstrual device to self-expand to a deployedconfiguration.

The support element 17 allows the passage of menstrual fluid through thesupport element 17, and therefore does not provide a fluid sealingfunction. For example, the support element 17 may be formed, at least inpart, from one or more materials arranged as a mesh. In theseembodiments, the support element 17 is not limited to any particulartype of mesh arrangement provided the mesh can be elastically deformedor folded into a compact configuration and can also be expanded into anexpanded configuration. Some examples include braided mesh. The supportelement 17 is not, however, limited to being formed as a mesh, or havingone or more portions formed as a mesh. For example, the support element17 may be formed in part from a woven material, a perforated material,or a non-porous or solid material, or the like, or combinations thereof.

The support element 17 is not limited to any particular type material,however medical grade and/or biocompatible materials are preferred.Non-limiting examples of materials that may be used to form a meshsupport element 17 include any rigid or semi rigid materials, such aspolyolefins (i.e. polypropylene, polyester, and polyethylene),thermoplastic elastomers, nylons, and silicones. In some embodiments,the mesh support element 17 is non-absorbent in its own right. In someembodiments, the mesh support element 17 assists in retention andstorage of fluid within menstrual device 10. In some embodiments, themesh support element assists in directing fluid into and/or withinmenstrual device 10.

The absorbent element 19 comprises a material operable to absorbmenstrual fluids either physically or chemically, or some combinationthereof. The absorbent element 19 is capable of being elasticallydeformed or folded into a compact configuration and can also be disposedinto an expanded configuration; i.e., disposed in a deployedconfiguration or an at rest configuration.

In some embodiments, the absorbent element 19 is configured toelastically self-expand; e.g., if radially compressive forces less thanthose required to hold the absorbent element 19 in a compactconfiguration are applied to the absorbent element 19, theself-expanding absorbent element 19 will radially expand into a deployedconfiguration, or if no radially compressive forces are applied to theabsorbent element 19, the self-expanding absorbent element 19 willradially expand into an at rest configuration. In the at restconfiguration, the self-expanding absorbent element 19 assumes apredetermined geometric shape. The elastically self-expanding absorbentelement 19 expands without utilizing any liquid (absorbed or otherwise)as a mechanism of change. This type of absorbent element 19 may bereferred to as having an “elastic memory”. In other embodiments, theabsorbent element 19 does not elastically self-expand, or is incapableby itself of causing the menstrual device to self-expand to a deployedconfiguration.

For those embodiments where the absorbent element 19 is configured toelastically expand, an acceptable absorbent element material is anelastic polymer that can be formed into a geometric shape useful for amenstrual device 10; e.g., an elastic polymer formed to assume a desiredgeometric shape and volume in an at rest configuration (i.e., in theabsence of applied forces) and which polymer can be elasticallycompressed to a smaller volume and thereby assume a reduced volumeconfiguration (e.g., a deployed configuration or a compactconfiguration). Specific non-limiting examples of elastic polymersinclude medical grade and/or biocompatible polyester, polypropylene, orpolyurethane foams. The term “foam” as used herein refers to a substrateconstruction having internal voids, which voids may vary in size andnumber per volumetric unit.

For those embodiments where the absorbent element 19 does notelastically self-expand, acceptable absorbent element materials include,but are not limited to, wood pulp, rayon, cotton, natural or syntheticnonwoven materials, super-absorbent materials (e.g., fibers, films,particles), nanocellulose materials, foams, or any combination thereof.The absorbent material(s) 16 is preferably medical grade and/orbiocompatible.

As indicated above, embodiments of the present menstrual device 10include a frame 12 having at least one side wall 20, a distal end 22, aproximal end 24, and an interior cavity 26, wherein the interior cavity26 may be completely defined by the interior surface 32 of the side wall20, or may be defined by the interior surface 32 of the side wall 20 andthe interior surface 38 of the distal end 22. At least a part of theframe side wall 20 includes both the support element 17 and theabsorbent element 19. In some embodiments (as can be seen in FIGS.12-12D), the support element 17 is disposed radially outside of theabsorbent element 19. The support element 17 may extend the entirety ofthe side wall (from proximal end to distal end; outside of the absorbentelement 19, or less than the entirety. In some embodiments, the supportelement 17 is disposed radially inside of the absorbent element 19. Forexample, FIG. 12C shows an embodiment wherein the entirety of thesupport element 17 is disposed radially inside of the absorbent element19. In any embodiment having at least a portion of the support elementradially inside of the absorbent element 19, the support element 17 mayextend the entirety of the side wall (from proximal end to distal end)radially inside of the absorbent element 19, or less than the entirety.In some embodiments (as can be seen in FIGS. 12A and 12D), the supportelement 17 may include a portion disposed radially outside of theabsorbent element 19 and a portion disposed radially inside of theabsorbent element 19. For example, the embodiment shown in FIG. 12Dincludes an outer support element portion 17A and an inner supportelement portion 17B, which portions are independent of one another. Theembodiment shown in FIG. 12A includes an outer support element portion17A and an inner support element portion 17B, and also includes aproximal end support element portion 17C that is connected to the otherportions 17A, 17B. In other words, the support element 17 embodimentshown in FIG. 12A extends from a radially outer portion 17A (e.g.,disposed on the interior surface 32 of the side wall 20), over theproximal end surface 36 (e.g., proximal end portion 17C), to a radiallyinner portion 17B (e.g., disposed on the exterior surface 34 of the sidewall 20). The support element 17 may extend around the entirecircumference of the menstrual device 10.

As described above, some embodiments of the present menstrual deviceinclude a frame 12 having a support element 17 that is configured toelastically self-expand. In some of these embodiments, it is the supportelement 17 that solely provides the radial expansion force (describedbelow) adequate to cause the menstrual device 10 to elasticallyself-expand from a compact configuration to a deployed configuration oran at rest configuration. Also as described above, some embodiments ofthe present menstrual device include a frame 12 having an absorbentelement 19 that is configured to elastically self-expand. In some ofthese embodiments, it is the absorbent element 19 that solely providesthe radial expansion force adequate to cause the menstrual device 10 toelastically self-expand from a compact configuration to a deployedconfiguration or an at rest configuration. In still other embodiments ofthe present menstrual device 10, the support element 17 and theabsorbent element 19 both provide radial expansion forces and therebycollectively provide the radial expansion forces necessary to cause themenstrual device 10 to elastically self-expand from a compactconfiguration to a deployed configuration or an at rest configuration.

The mechanical material properties of the frame material(s) that enablethe frame 12 to elastically expand from a compact configuration to anexpanded configuration may be described in terms of “expansion forces”.To illustrate, consider a frame 12 maintained in a deployedconfiguration (i.e., wherein the menstrual device 10 assumes a volumeless than the volume of the same device in an at rest configuration).Body wall surfaces 50 (i.e., vaginal wall surfaces) in contact with themenstrual device 10 prevent the menstrual device 10 from assuming itsfully expanded configuration, and thereby maintain the menstrual device10 in the partially compressed deployed configuration. As a result, theexpansion forces 51 that would otherwise cause the menstrual device 10to elastically expand to an at rest configuration, now act against thebody wall surfaces 50. Those expansion forces 51, which arequantifiable, are at least a part of the mechanism that enables themenstrual device 10 to be maintained at a particular position within theuser's vagina. It should be noted from the above that menstrual devices10 according to the present disclosure are intended to assume anexpanded configuration, albeit one that is partially compressedconfiguration (i.e. a deployed configuration), during in vivo use. Theexpansion forces 51 are described as being “at least part of themechanism” that enables the device to be positionally retained becauseother factors may also play a part in retaining the device; e.g., thecoefficient of friction of the exposed surface of the seal layer 28, thecoefficient of friction of the body wall surface 50, the geometric shapeof the menstrual device 10, etc. For the present menstrual deviceembodiments, the frame 12 is chosen to have mechanical materialproperties (as described above) that produce expansion forces adequateto retain the device 10 in vivo in a deployed configuration, while atthe same time such expansion forces 51 are preferably below a magnitudethat: a) would cause user discomfort; b) inhibit or prevent themenstrual device 10 from being placed in a compact configuration (e.g.,for insertion purposes with or without an applicator); and/or c) inhibitremoval of the menstrual device from in vivo deployment. The expansionforces 51 produced by the frame material are further discussed below inthe context of an applicator device that may be used with the presentmenstrual device 10.

As shown in FIGS. 13-15A, the menstrual device further includes a flange13 that further mitigates against leakage. Flange 13 provides agasketing effect thereby assisting with creating a seal with the vaginalwall. Flange 13 is flexible such that it is configurable in a compactform (i.e. it can fold or scrunch). In some embodiments, flange 13extends outwardly from exterior surface 34 of the menstrual device 10.In further embodiments, flange 13 extends outward and upward from theexterior surface 34 and proximal surface 36. In other embodiments,flange extends outward and downward from the exterior surface 34 andproximal surface 36. As flange 13 is flexible, it can be dynamic (i.e.move upward/downward, outward/inward) depending on placement within thevaginal wall and other factors such as the user's physical movementand/or the dynamic state of other organs/tissues. In some instances,flange 13 can actually create a dam and not only assist in collectingfluid within the menstrual device 10, but above the proximal surface 36.

Flange 13, as shown in FIGS. 8A-9B, and 14-15A, has multiple flanges13A, 13B, and 13C. These additional flanges further assist in creating aseal with the vaginal wall, due to dynamic conditions experienced overtime. Flanges are separated by grooves 15, 15A, 15B, and 15C. Flanges 13and grooves 15 can be discrete from each other, continuous about theperiphery of the menstrual device 10, and/or varied, patterned, etc.Flanges 13 are generally sized to extend outward widthwise or depthwiseup to 0.5 inches, less than 0.35 inches, or between about 0.01 inchesand about 0.3 inches. Flanges 13 are generally sized to extend in lengthalong the lengthwise axis up to 0.5 inches, less than 0.35 inches, orbetween about 0.01 inches and about 0.3 inches. Grooves 15 have similarrange of sizes.

As depicted in FIGS. 8A-9B, flanges 13 extend from frame 12. Seal layer28 extends up to the inferior-most flange 13B. Although seal layer canextend and at least partially cover portions of a flange or flanges (orgroove or grooves), it is preferred at least a portion of a flange (orflanges) is not covered by seal layer 28 such that, depending on how themenstrual device 10 is positioned within the vaginal canal, it enablesfurther fluid collection through the permeable frame 12. As depicted inFIGS. 13-15A, flanges extends from support element 17. In embodimentswhere the seal layer 28 is the supper element 17, the flange 13 (orflanges) extends from the seal layer 28/support element 17.

As shown in FIGS. 13 and 15A, the menstrual device 10 includes flange 15in the form of a pocket or gusset. Optionally, one or more support ribs21 (as shown in FIG. 15A) provide added resilience to flange 13 tomitigate against bypass leakage (by improving the seal created with thevaginal wall).

The support element 17 and the absorbent element 19 may be attached toone another directly or indirectly. Non-limiting examples of acceptableattachment mechanisms include adhesive, mechanical fasteners, bonding,etc. An example of an indirect attachment mechanism includes both thesupport element 17 and the absorbent element 19 being attached to theremoval element 14, but not directly to each other.

The seal layer 28 is disposed on at least a portion of the exterior ofthe menstrual device 10. In those embodiments where the support element17 is disposed radially outside of the absorbent element 19, the seallayer 28 may be disposed radially outside of the support element 17(e.g., see FIGS. 12A, 12B, and 12D). In these embodiments, the seallayer 28 may be disposed on the entirety of the exterior surface of thesupport element 17, or on less than the entirety of the support element17. In those embodiments wherein the support element 17 extends lessthan the entire distance between the proximal end and the distal end ofthe menstrual device, the seal layer may also be disposed on a portionof the exterior surface 34 of the side wall 20. In those embodimentswherein the support element 17 is only disposed radially inside of theabsorbent element 19, the seal layer 28 may be disposed on the entiretyof the exterior surface 34 of the side wall 20 (e.g., the entiredistance between the proximal end and the distal end, and contiguouswith the absorbent element 19; see FIG. 12C), or less than the entiretyof the exterior surface 34 of the side wall 20. In some embodiments, theseal layer 28 may cover at least a portion of the proximal end surface36. In those embodiments wherein the frame 12 includes a distal endexterior surface 40, the seal layer 28 may also be disposed on thedistal end exterior surface 40.

The removal element 14 is typically disposed at the distal end 22 of themenstrual device 10 and is configured to facilitate removal of themenstrual device 10 from the user's vagina. The removal element 14 maybe a component independent of the frame 12 or seal layer 28, butattached to one or both of the frame 12 and seal layer 28. An acceptableexample of an independent removal element 14 is a string. The use ofstrings as a menstrual device 10 (e.g., a tampon or menstrual cup) iswell known in the art, and therefore further description is not providedherein. In some embodiments, the removal element 14 may be incorporatedinto the frame 12 or seal layer 28; an extension of the frame 12 or theseal layer 28, or some combination thereof.

The removal element 14 is typically disposed at the distal end 22 of themenstrual device 10 and is configured to facilitate removal of themenstrual device 10 from the user's vagina. The removal element 14 maybe a component independent of the frame 12 or seal layer 28, butattached to one or both of the frame 12 and seal layer 28. In regards tothe removal element 14 being attached to the frame 12, the removalelement 14 may be attached to one or both of the support element 17 andthe absorbent element 19. An acceptable example of an independentremoval element 14 is a string. The use of strings as a menstrual device10 (e.g., a tampon or menstrual cup) is well known in the art, andtherefore further description is not provided herein. In someembodiments, the removal element 14 may be incorporated into the frame12 or seal layer 28; an extension of the frame 12 or the seal layer 28,or some combination thereof.

In some embodiments, the seal layer 28 can be folded over itself andsealed to itself (in its entirety or minimally at the end points 31 ofthe fold(s) 33 to provide multiple layers in the seal layer 28. Endpoints 31 are a single node or describe a peripheral end point forattachment. One skilled in the art understands that in any embodimenthaving a seal layer 28, end points 31 are minimally included (i.e., anupper end point that is discrete or peripheral, and a lower end pointthat is discrete or peripheral). This is advantageous in that itprovides redundancy in impermeability, particularly at the distal end22, and it also improves the strength of seal layer. The seal layerstrength is further advantageous when positioned in the bottom region ofthe menstrual device and can ultimately become the removal element inits entirety. In some embodiments, a further removal element (i.e. astring, coated string, braided string) can be attached to the foldedseal layer 28. The folded seal layer at least about the bottom region(or in some embodiments, merely the distal exterior surface 40) providesadded strength as it distributes what is typically a tensile load on theremoval element 14 with through shear.

As shown in the embodiment in FIG. 17, seal layer 28 extends beyond thedistal end 22. In such embodiments, seal layer 28 provides covering overa removal element 14, can be used to fasten the removal element 14 tothe menstrual device 10, and/or be sealed to form a further fluidcollection reservoir 29.

In other embodiments, the seal layer 28 and/or support layer 17 extendto form a ring 23 with hole 25, as shown in FIG. 15A. A removal element14 can be fastened to the ring via a knot 11. In alternate embodiments,as shown in FIGS. 16-17, a removal element 14 is stitched or otherwiseattached to the menstrual device 10. Removal element 10 is attached viaone or more knots, and can be attached along the lengthwise axis (asshown in FIG. 17), and/or can be attached just above either astep-change 17 in the cavity 26 and/or just above the bottom of thecavity 26. Attaching the removal element 14 as such improves the tensilestrength.

All embodiments as contemplated in the present disclosure of the removalelement 14 have been tested and meet the FDA's tampon requirements forhaving a tensile strength of at least eight pounds (i.e. stitched,knotted in the cavity, applied to the menstrual device by biocompatibleadhesive, and/or tied to ring 25).

In some embodiments of the present disclosure, the menstrual device 10may include a second absorbent element 18 (independent of the absorbentelement 19) disposed within the interior cavity 26 of the frame 12(e.g., see FIG. 6A). An example of a second absorbent element 18 is atampon pledget, and can include materials such as rayon (multilobal,single lobal, cotton and/or combinations thereof). Tampon pledgets arewell known in the art and the present menstrual device 10 is not limitedto including any particular type of tampon pledget (i.e. including thosewith or without coverstock, formed wadded material and/or includingdiscrete layers or pads). The second absorbent element 18 may be coupledto the frame 12 using one or more techniques; e.g., by adhesive,ultrasonic bonding, stitching, mechanical features, etc.

In some embodiments, menstrual device 10 includes a support element 17and either absorbent layer 19 or second absorbent element 18. In someembodiments, the support element 17 is elastic and as the absorbent(element 18 or layer 19) absorbs fluid, the support element 17 expands.In such embodiments, support element helps create a seal and thusmitigates against bypass leakage.

In some embodiments of the present disclosure, the menstrual device 10may include an absorbent article 18 disposed within the interior cavity26 of the frame 12 (e.g., see FIGS. 5A and 5B). An example of anabsorbent article 18 is a tampon pledget. Tampon pledgets are well knownin the art and the present menstrual device 10 is not limited toincluding any particular type of tampon pledget. The absorbent article18 may be coupled to the frame 12 using one or more techniques; e.g., byadhesive, ultrasonic bonding, stitching, mechanical features, etc.

In addition to, or as an alternative to the absorbent article 18, themenstrual device 10 may include one or more absorbent materials 16disposed within the interior cavity 26; e.g., disposed on at least partof the interior surface 32 of the frame side wall 20 defining theinterior cavity 26 (e.g., see FIGS. 4A and 413) The absorbentmaterial(s) 16 may comprise one or more material types; e.g., wood pulp,rayon, cotton, natural or synthetic nonwoven materials, super-absorbentmaterials (e.g., fibers, films, particles), nanocellulose materials,foams, or any combination thereof. The absorbent material(s) 16 ispreferably medical grade and/or biocompatible.

Now referring to FIG. 19, in some instances the present menstrual device10 may be configured for use with an applicator 52 that facilitatesdeployment of the menstrual device 10 within the user's vagina. Thecombination of applicator 52 and menstrual device 10 may be referred toherein as a menstrual device system. Although the present menstrualdevice 10 is not limited to use with any particular type of applicator52, an example of an acceptable type applicator 52 is a plunger typeapplicator having a barrel 54 and a plunger 56. The barrel 54 has atubular configuration with an interior cavity 58 extending between aninsertion tip end 60 and a plunger end 62. The insertion tip end 60 mayhave a plurality of slits 64 that form petals 66 that normally assume aradially inward geometry to give the insertion end a taperedconfiguration. The plunger 56 is receivable within the barrel interiorcavity 58 and has a mating geometry relative to the barrel interiorcavity 26 such at least a portion of the plunger 56 can be inserted intothe barrel interior cavity 26; i.e., the plunger 56 can be moved axiallyinto the barrel interior cavity 26. A menstrual device 10 disposed in acompact configuration can be disposed within the barrel interior cavity26. Axial insertion of the plunger 56 into the barrel interior cavity 26will axially move the menstrual device 10 against the petals 66.Continued axial insertion of the plunger 56 will cause the petals 66 todeflect radially outward and the menstrual device 10 to eject from thebarrel 54.

The “Ejection Force” is described as the force required to eject amenstrual device 10 from the applicator. The Ejection Force can bedetermined using a scale such as a Tronix scale model #WI-130, and anInstron model 5944 with a 100 N load cell, using a rate of 12 in/min,and by following this procedure. All menstrual device 10 samples testedhad a small amount of lubricant (K-Y True Feel Silicone Lubricant)applied to their periphery before being loaded into the applicators, asdiscussed below. The amount of lubricant included was minimal, such thatupon ejection, no lubricant was noticeable by touch.

Procedure: Ejection Force

-   -   1. Zero out the scale and ensure it is weighing in ounces of        (other units of Force are also acceptable, such as Newtons).    -   2. Grasp the applicator (containing a tampon) by the finger grip        using the thumb and index finger. Place the applicator, plunger        end down, on top of the balance platform. Apply a steady        downward motion until the menstrual device is ejected from the        barrel. Apply the least amount of pressure possible while        ejecting the menstrual device from the barrel.    -   3. Record the maximum Ejection Force indicated by the scale        (Note: the Ejection Force is recorded automatically if the scale        is used in conjunction with computer running data. collection        software).

In those embodiments wherein the present menstrual device 10 is intendedto be used with an applicator 52 (e.g., the same as or similar to theapplicator described above), the frame material(s) is chosen to havemechanical material properties that produce expansion forces below whichthe menstrual device 10 is detrimentally inhibited from being ejectedfrom the applicator 52; i.e., the frame material expansion forces do notbind the menstrual device 10 within the applicator barrel 54. In suchembodiments, the seal layer 28 material properties (e.g., surfacefinish) and the applicator barrel 54 material properties (e.g., surfacefinish) may be chosen to complement each other to facilitate ejection ofthe menstrual device 10 from the applicator barrel 54. For instance, theseal layer 28 is a smooth and/or slippery material such that itscoefficient of friction is less than that of the frame 12 material. Assuch, seal layer 28, when applied to frame 12, can, in embodimentsincluding an applicator 52, reduce the ejection force of the menstrualdevice 10 from applicator 52 to be less than 50 ounces, less than about40 ounces, preferably less than 30 ounces and more preferably, less thanor equal to about 20 ounces.

As shown below in Table 2, applicators used to confirm ejection forcevalues included the PLAYTEX GENTLE GUIDE ultra, having an inside barreldiameter of 15.77 mm, the PLAYTEX SPORT super plus, having an insiderbarrel diameter of 14.34 mm, and the KIMBERLY CLARK POISE IMPRESSAapplicator, having an insider barrel diameter of 19.03 mm. In short,applicators having an inside barrel diameter of between about 14 mm andabout 20 mm are suitable for the menstrual device 10 of the presentdisclosure, or between about 14.25 mm and about 19.5 mm, or between 15mm and about 19 mm. Various sizes of menstrual device 10 were used,including those with lengths of 1.5″ and 1.75″, having proximal endwidths of 1.5″ and 1.75″, a cavity length of 0.25″, 0.50″ and 0.75inches, with a maximum cavity radius at the proximal end of 0.75″, 1″and 1.08″. If not otherwise specified, the samples included a seal layer28 made from a biocompatible film. At least five samples of eachembodiment of the menstrual device 10 were tested.

As shown in the embodiment in FIG. 18, the ejection force changes duringthe ejection process, or as a function of time or length (note: lengthand time are related due to the 12 in/min rate, and the length of thestroke correlates to the length of the plunger moving against themenstrual device). FIG. 18 (reference numeral 210) describes variousstages of ejection, starting with the plunger 56 initially contactingand depressing the menstrual device 10 at a force that exceeds that ofthe friction between the exterior surface of the menstrual device 10 andthe interior surface of cavity 58 of the applicator 52 barrel 54 (seereference numeral 200). The vertical axis 214 describes ejection forcein ounces, while the horizontal axis 212 describes extension of theplunger in inches. Once the force exerted by the plunger 56 exceeds thisstatic friction force, the ejection force drops slightly as themenstrual device 10 begins sliding through the applicator barrel 54prior to making contact with and opening the insertion tip end 60 of theapplicator (see reference numeral 202). As the menstrual device 10approaches the insertion tip end 60 and begins to apply pressure againstthe insertion tip end 60, the force increases until the insertion tipend 60 has been opened (see reference numeral 204). Once the insertiontip end 60 is opened, the menstrual device 10 starts to eject from theapplicator at a reduced force (i.e. “self-ejection”; see referencenumeral 206). Lastly, as shown by reference numeral 208, the menstrualdevice 10 goes through the final stages of ejection at a low level offorce.

The menstrual device 10 has numerous distinct ejection characteristics,including the ability to self-eject from the applicator 52 after theplunger 56 has moved at least about an inch. The plunger's 56 movementof at least about an inch has fully opened the applicator insertion tip60. The plunger's 56 movement of at least about an inch has engaged themenstrual device 10 such that a substantial portion of the menstrualdevice 10 has been pushed beyond the applicator 52 insertion tip end 60.

Various embodiments of the menstrual device 10 of the present disclosureinclude various features. For instance, menstrual device 10 has a frame12 which is optionally a support member 17 and absorbent material (18 or19). A single material can act as either or both of a support member 17and a seal layer 28, and in further embodiments, provides all or aportion of removal element 14.

While some of the examples described herein related to uses of a deviceconfigured to be deployed within a body cavity, aspects of thedisclosure may be applied in other types of environments where fluidsealing, absorption, or collection may be needed; e.g., incontinencedevices. etc.

While the present disclosure has been described with reference to one ormore exemplary embodiments, it will be understood by those skilled inthe art that various changes may be made and equivalents may besubstituted for elements thereof without departing from the scope of thepresent disclosure. In addition, many modifications may be made to adapta particular situation or material to the teachings of the presentdisclosure without departing from the scope thereof. Therefore, it isintended that the present disclosure not be limited to the particularembodiment(s) disclosed as the best mode contemplated, but that thedisclosure will include all embodiments falling within the scope of thepresent disclosure.

1. A menstrual device comprising: a frame having a side wall with anexterior surface and an interior surface, the side wall extends betweena proximal end, and a distal end, and the interior surface at least inpart defines an interior cavity; and a fluid barrier seal layer disposedon the exterior surface of the side wall, the fluid barrier seal layerattached directly to the exterior surface about at least a first endpoint; wherein the menstrual device collects fluid, wherein themenstrual device has a device length defined by a central vertical axisbetween the proximal end and the distal end, and wherein the menstrualdevice is configurable in a compact configuration and in an expandedconfiguration, and in the expanded configuration the interior cavity hasa volume greater than zero.
 2. The menstrual device according to claim1, wherein the distal end has an interior surface and the interiorcavity is defined by the interior surface of the side wall and theinterior surface of the distal end.
 3. The menstrual device according toclaim 2, wherein the fluid barrier seal layer is disposed on less thanall of the exterior surface of the side wall.
 4. The menstrual deviceaccording to claim 2, wherein the fluid barrier seal layer is disposedon all of the exterior surface of the side wall.
 5. The menstrual deviceof claim 4, wherein the proximal end includes a proximal end surface,and the fluid barrier seal layer is disposed on at least a part of theproximal end surface.
 6. The menstrual device of claim 1, wherein thefluid barrier seal layer comprises at least one of a molded orthermoformed polymer, a flexible film, or a hydrophobic nonwovenmaterial.
 7. The menstrual device of claim 1, wherein the frame has agram per gram absorbency of greater than or equal to 5 g/g as measuredby the syngyna apparatus using a 1% saline solution and a flow rate of0.8 ml/min.
 8. The menstrual device according to claim 1, wherein thecavity has a cavity length that is less than or equal to half of thedevice length.
 9. The menstrual device of claim 1, wherein the fluidbarrier seal layer end point is peripheral.
 10. The menstrual device ofclaim 9, wherein the fluid barrier seal attaches to a withdrawalelement.
 11. The menstrual device of claim 1, wherein the fluid barrierseal layer includes a second end point such that the first end point iscloser to the proximal end and the second end point is closer to thedistal end.
 12. The menstrual device of claim 1, wherein the barrierseal layer is vacuum formed onto the frame.
 13. The menstrual device ofclaim 1, wherein the frame comprises a support element and an absorbentelement.
 14. (canceled)
 15. The menstrual device of claim 13, wherein atleast one of the support element or the absorbent element is configuredto elastically self-expand, and thereby cause the menstrual device toradially expand from the compact configuration to the expandedconfiguration in the absence of radially compressive forces.
 16. Themenstrual device of claim 13, wherein the support element is configuredto cause the menstrual device to radially expand from the compactconfiguration to the expanded configuration in the absence of radiallycompressive forces by itself.
 17. The menstrual device of claim 13,wherein the absorbent element is configured to cause the menstrualdevice to radially expand from the compact configuration to the expandedconfiguration in the absence of radially compressive forces by itself.18. The menstrual device according to claim 12, wherein the supportelement includes a silicone material.
 19. The menstrual device accordingto claim 1, further comprising at least one flange extending outwardfrom the proximal end.
 20. A menstrual device comprising: a frame havinga side wall with an exterior surface, the side wall extends between aproximal end; and a fluid barrier seal layer disposed on the exteriorsurface of the side wall and is directly attached to the frame at leastat a first point of attachment; wherein the menstrual device collectsfluid, and wherein the menstrual device is configurable in a deployedconfiguration and in an at-rest configuration, the deployedconfiguration having a deployed footprint and the at-rest configurationhaving an at-rest footprint, and wherein the deployed footprint that isup to or equal to 100% of the at-rest footprint.
 21. The menstrualdevice according to claim 1, wherein the cavity comprises at least twocavities.